FDA 483 - Kobo Products, Inc - May 09, 2025

Kobo Products, Inc. in South Plainfield, NJ, an API manufacturer, was cited for four significant observations during an FDA inspection from May 2-9, 2025. The firm failed to establish adequate production and process controls, including process validation for Zinc Oxide and Titanium Dioxide API drug products. Additionally, issues were noted with equipment validation, cleaning validation, and computer system controls, specifically regarding unauthorized access and data alteration in the QC laboratory.